What exactly is happening with AstraZeneca?

It is also a product that is made in multiple plants by contract manufacturers in a complex supply chain. The U.K. supplies, for example, may not even be coming from the same supply chain or stock.

Biotech products are made in processes using living cells and viruses. So you’re dealing with something that has more in common with brewing in the sense that it’s a biological process rather than manufacturing using chemicals as in traditional pharma.

It’s hopefully nothing, but it needs to be followed up. You cannot just assume just because the U.K. hasn’t seen an issue that the issue doesn’t exist elsewhere. They may not be using precisely the same product from the same plants.

It doesn’t mean there’s anything wrong with the overall product - it could be anything from a manufacturing issue, a filling issue, a storage issue, a problem with syringes used or, just a freak blip in the data caused by a cluster that’s totally unrelated to the vaccine.

That’s why you need to be able to get to the bottom of it. Most likely they will withdraw a batch but they’ll have to check the whole way though everything and they should hopefully have an answer to this rapidly.

In all likelihood, is probably nothing of concern but, but until they establish that it’s obviously raised an alarm that’s loud enough to have multiple countries pause to gather the facts.

plodder wrote: »

Was just about to ask a similar question. If it's not a batch issue, how do we know it's not a "factory" issue?

At the moment we don’t know anything, which is why there’s a pause. They’ll be going through data.

Every dose is linked to a batch so, they’ll be able to see if it occurred in just an isolated number of cases at random or if there’s a link to a batch.

You could even have something like an unrelated outbreak of some other illness that impacted a cluster of people. You could discover there’s some unusual reaction amongst a group of people who are perhaps genetically related and have a weird immune response.

It could be a physical issue with storage etc etc etc or just some totally freak incident that is within the acceptable level of what you’d expect in any situation.

There are lots of explanations - most of which don’t implicate the product, but they need to be sure.

The vaccine has passed all the regulatory approvals and has been rolled out in the U.K. to millions without any problems, so it’s not at all likely to be a general issue with the vaccine itself as a technology or product.

I would compare this to the aviation regulatory authorities grounding a major, very safe airliner because of a report of some odd cluster of incidents. It’s just part of active regulatory monitoring and it’s better to find any potential glitch, rule it out or solve it than to just assume it’s nothing and carry on regardless.

It’s not unusual for this to happen in highly regulated areas like medicine, aviation, nuclear power, transport services like closing a bridge due to a concern that subsequently turns out to be nothing etc etc

There’s a precautionary principle that’s followed in this kind of regulatory environment and it is very fundamental to keeping people safe but also to ensuring confidence too.

I think it’s very wrong footed to assume this is an slur on a particular vaccine or that it’s anything unusual. It’s a useful procedure and part of the framework of ensuring the rollout goes smoothly by ironing any issues before they can become anything of significance.

We need to park politics and conspiracy theories and just get on with it. There’s a bigger picture issue of ensuring that the vaccination programme is smooth, safe and has public confidence and proactive regulation is a big part of that.